sleep apnea story on A Current Affair

Oventus has no control over the content and production of this video. Oventus use it with permission from the CSIRO. Before making any change to your sleep-disorder treatment, seek medical advice from a sleep physician.

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Oventus are sponsoring upcoming clinical trials using the new generation O2Vent


dental surgery (Small)

Oventus are sponsoring upcoming clinical trials using the new generation O2VentTM oral appliance for the treatment of Obstructive Sleep Apnoea.

Breathing Assist Solutions in Brisbane are currently looking for volunteers who suffer from Obstructive Sleep Apnoea to participate in these trials. Places are limited so please call as soon as possible on 1300 416 743 to nominate your interest and find out if you are eligible.

More information on the clinical trial can be found below:

Safety and efficacy of Oventus O2VentTM and the effect of incorporation of an enclosed airway on compliance in patients with obstructive sleep apnoea

ACTRN12616000740493 HREC approval from Bellberry

The O2VentTM is a novel oral appliance for the treatment of snoring and obstructive sleep apnoea. It is the only device with a built in airway that allows patients to breathe through the device.

The primary objectives of this study are to demonstrate:
1. the safety and efficacy of Oventus O2VentTMoral appliance and
2. that the incorporation of an enclosed airway improves comfort and compliance

Participants with mild-moderate OSA or CPAP intolerant severe OSA are eligible to participate.

Participants will be fitted with a customised oral appliance. Sleep studies at baseline will be performed before an acclimatisation period and treatment optimisation with O2VentTM. Additional sleep studies and rhinomanometry will be conducted at the end of 2 weeks of treatment with a) the device airway open and b) device airway closed. Sleep symptoms, usage and comfort will be assessed during this time.

Research is being conducted in Brisbane. Please contact Breathing Assist Solutions on 1300 416 743 for more information.

48 thoughts on “Oventus are sponsoring upcoming clinical trials using the new generation O2Vent”

  1. I have an obstructive flap in my throat and currently use a nose mask CPAP machine.
    May I participate in the trial?
    Projected cost of mouthguard against a CPAP machine
    Thanks
    Andrew Adam

    1. Hi Adam, thanks for your query. Please can we ask you to contact us on 1300 416 743 to discuss your eligibility for participation in the trial. Total treatment cost of the O2Vent device will be in the range of $2000-2500 including the custom made device and related dental consults and procedures with an accredited Oventus cliician.

  2. I have a full denture plate on top & a partial plate on my lower with only 2 eye teeth on lower jaw is the devise okay with dentures?

    1. Hi Glenn, unfortunately the O2Vent T device will not retain sufficiently with only 2 eye teeth. We are currently at a research and development stage for a “tongue retainer” device to cater for patients with dentures. We are more than happy to add your details to our list for contacting once this device has finished testing and is available. We have noted your name and email address and will contact you when we are in a position to offer this device. Thank you.

  3. Hi,
    I have dentures both top and bottom. I spoke to you guys some time ago and I believe that you were working on a design so that people with dentures are able to use your product. Do you in fact have that product design yet?

    Regards,
    Kerry

    1. Hi Kerry, the device you are referring to is the “tongue retainer” which is still in the research and development stage. We are more than happy to add your details to our list for contacting once this device has finished testing and is available. We have noted your name and email address and will contact you when we are in a position to offer this device. Thank you.

  4. I am interested in taking part as I do snor a fair bit I am told. Sometimes waking up with a bad headache and very dry throat, feeling tired for most of the day.

    1. Thanks for your query Robyn. If you are Brisbane based can I encourage you to call Breathing Assist Solutions on 1300 416 743 to discuss whether you are a suitable candidate for the study? Alternatively if you would like to send a private email to brisbane@breathingassist.com.au with your contact details, we can call you directly.

    1. Thanks for your comment Heather. The tongue retainer device is still at a research and development stage so trials are not likely to be held until at least 12 months time. We will add your name to the list of interested patients. If you are a partial denture wearer and have 6 permanent teeth you may be suited to the Oventus O2Vent device. Feel free to call us on 1300 533 159 if you would like to discuss. Thank you.

  5. Hi, can I form part of this trial?
    My sleep apnea was diagnosed as severe, and I can’t afford the regular mask as per is too noisy.
    Please contact me

    1. Thanks for your query Claudia. Are you Brisbane based? We have some questions we need to ask to determine if you are a suitable candidate for the clinical trial. Are you able to send us a Personal Message with your phone number so we can call you at a suitable time? If we don’t hear from you we will email you. Thank you.

  6. Hi

    I have sleep and have the CPAP machine but couldn’t stand it. It wakes me up in the middle of the night. Can i participate please?

    I am brisbane based.

    Thank you

    1. Thanks for your query Blair. A member of the clinical trials team will make contact with you to determine whether you are a suitable candidate for participating in the trials.

  7. Hi – I have severe obstructive sleep apnea and am located in Brisbane. Would be very interested in learning more about participating in this trial. Many thanks.

    1. Thanks for your query Sandra. A member of the clinical trials team will make contact with you to provide information and determine whether you are a suitable candidate for the trial.

  8. I have OSA and am located in the USA. I am intolerant to the CPAP masks and cannot wear them. Will you be conducting any clinical trials in the USA? If not, how would I go about ordering the 02Vent device once it is FDA approved. I am very interested in trying an innovation that could possibly work for me.
    Many Thanks!

    1. Thanks for your message Jan. The O2Vent Mono device already has FDA approval in the USA and we anticipate that we will receive clearance on the O2Vent T (titratable) device in the fourth quarter of this year. Can we ask where you are located in America? We are finalising beta sites to start operation in November, so could advise where the nearest site is. Thank you.

  9. I have moderate OSA and would be interested in participating in the trial if there are still available places. I live in Brisbane.

    1. Thanks for your query Heather. We have some questions we need to ask. A member of the clinical trials team will make contact with you to determine whether you are a suitable candidate for participating in the trials.

    1. Thanks for your query Sheree. Are you Brisbane based? We have some questions we need to ask. A member of the clinical trials team will make contact with you to determine whether you are a suitable candidate for participating in the trials.

  10. Trevor has been diognised with severe sleep apnea but will not wear his mask and I am very worried about him we are in Brisbane and he is interested in trying your product thanks

    1. Hi Sharyn, thanks for your query about Trevor. We have some questions we need to ask. A member of the clinical trials team will make contact with you to determine whether Trevor is a suitable candidate for participating in the trials.

  11. I have been diagnosed with severe S A have used 2 masks last one being a hummedifier & badly infected my sinuses. Aged 72 , would I be able to participate? Loveina

    1. Hi Loveina, thanks for your query Heather. A member of the clinical trials team will make contact with you to ask some questions and determine whether you are a suitable candidate for participating in the trials.

    1. Thanks for your query Wendy. We have some questions we need to ask. A member of the clinical trials team will make contact with you to determine whether you are a suitable candidate for participating in the trials.

    1. Hi Marianne, no there are no costs associated with participating in the trial. However we do have to ask you some questions to determine whether you would be a suitable candidate. We also need to ask whether you are Brisbane based. If you are in Brisbane, we would ask that you call Breathing Assist Solutions on 1300 416 743 to discuss further. Thanks and regards.

  12. I have been diagnosed with severe obstructive sleep apnea. I am 67, 167 cm tall, weigh 61.5 kgm. Have all my own teeth. I would like to be considered for a trial.

    1. Thanks for your email Christine and apologies for the delayed response. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower.
      For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a local clinician to make an appointment. Thank you

  13. I saw your report on a current affair and I am interested in taking part in the trial.
    I am a habitual snorer much to my wife’s discomfit and regularly wake with a sore dry throat, headache and am constantly tired as if I haven’t slept.

    I am Melbourne (Vic) Based.

    1. Thanks for your email Paul and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area only I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Melbourne that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to a Melbourne clinician to make an appointment. Thank you

  14. After watching your segment on Sunday Night, channel 9 news, i wish submit an expression of interest to become involved in your next clinical trial.

    1. Thanks for your email Danel and apologies for the delayed response. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show if you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower. Thank you.

  15. Hi, just wondering if you are still looking for people for trial. I am 4.5 years post heart transplant.I was diagnosed with sleep apnoea after transplant but found it difficult to cope with a CPAP machine and hence still suffer from extreme fatigue. Would be very interested in participating in your trial.

    1. Thanks for your email Ron and apologies for the delayed reply. The clinical trial is being held in Brisbane. Can I ask if you are Brisbane based? And if so, do you have a sleep diagnostic report from the past year to show that you suffer from obstructive sleep apnoea? If you answer yes to both questions please can we ask you to call us on 1300 533 159 so we can ask some additional questions to check your eligibility for the trial. The trial itself involves approximately 3 visits to our clinic in Taringa and 3 overnight sleep studies at a sleep centre in Auchenflower. Thank you.

    1. Thanks for your email Neville and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area only I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia and we have clinicians in a couple of SA locations. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an clinician near you to make an appointment. Thank you

  16. Hi. I have been tested and told I have very severe sleep apnoea. I was given a CPAP machine with a humidifier a few years ago. I had trouble breathing with it but my wife says it stopped my snoring. After I had to have open heart surgery last December (2015) I found it extremely difficult to use my CPAP. Even after the pressure was adjusted, I just could not breath properly. Turns out I have also had severe heart failure following my Atrial valve replacement and CBAG in December 2015. I was retaining way too much fluid on my lungs, this now seems better, after I was fitted with a “Medtronic’s” Defibrillator/Pacemaker in July 2016. BUT, I still snore like two chainsaws on full throttle, and can’t seem to tolerate the CPAP machine any more.
    Unfortunately I live in Penrith NSW so I guess would be ineligible for the Brisbane study, BUT, I really need some way of defeating my sleep apnoea. P.S. Since the heart failure (down to 24% function) and the open heart surgery I have lost weight from 124 kilo’s (Dec 2015) to 108 kilo’s now (Sep 2016).
    Kindest Regards.
    Graham Ross.

    1. Thanks for your email Graham and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia and we have clinicians in a few Sydney locations. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis and heart complications further. In some cases severe sufferers of sleep apnoea are advised to remain on CPAP. However if we could discuss further we could determine whether this device can assists and locate a clinician near you to make an appointment. Thank you

    1. Thanks for your email Marite and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area I’m afraid. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia and we have clinicians in a few Sydney locations. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an clinician near you to make an appointment. Thank you

  17. Hi

    I am based in Adelaide and have severe sleep apnea I have had a splint made by Adelaide dental hospital but I find this very uncomfortable Would I be considered for the trial

    thanks

    angela brown

    1. Thanks for your email Angela and apologies for the delayed response. The clinical trial is available to people who live in the Brisbane area. For patients outside of Brisbane, we are pleased to advise that the O2Vent device is commercially available at Oventus accredited clinics throughout Australia. We do have clinicians available in Adelaide that you could make a no-obligation appointment with to discuss your suitability for the device. If this is of interest to you, please call us on 1300 533 159 and we can discuss your sleep diagnosis further and transfer you to an Adelaide clinician to make an appointment. Thank you

  18. I was diagnosed with mild-moderate sleep apnea in June 2016. I was not able to tolerate the CPAP machine. I would like to participate in a clinical trial on this device. I live in the state of California (USA). Can you tell me if you have clinical trials where I can participate in the USA?

    1. Hi Anabel, thank you for your comment. Unfortunately there are only clinical trials being held in Australia at present. We are looking to launch the supply of our O2Vent T device in the new year (2017) where it will be available from accredited clinicians. If you would like we could take your details and contact you when the device is available. However this would not be as part of a trial. Let us know if this is of interest. Thank you.

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